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Safety of treatment with biologics for psoriasis in daily practice: 5-year data

Authors


  • Conflict of interest
    P.P.M. van Lümig has received funding from Wyeth for research and carries out clinical trials for Abbott and Janssen-Cilag. P.P.M. van Lümig has received speaking and consulting fees from Wyeth and Schering-Plough and has received reimbursement for attending a symposium from Schering-Plough and Pfizer. R.J.B. Driessen has received funding from Merck Serono and Wyeth for research and carried out clinical trials for Wyeth, Schering-Plough, Centocor, Abbott, Merck Serono and Barrier Therapeutics. R.J.B. Driessen has received speaking and consulting fees from Wyeth and Schering-Plough and has received reimbursement for attending a symposium from Merck Serono, Wyeth and Janssen-Cilag. M.A.M. Berends has no conflicts of interest to declare. J.B.M. Boezeman has no conflicts of interest to declare. P.C.M. van de Kerkhof serves as a consultant for Schering-Plough, Celgene, Centocor, Allmirall, UCB, Wyeth, Pfizer, Sofinnova, Abbott, Actelion, Galderma, Novartis, Janssen-Cilag and LEO Pharma. P.C.M. van de Kerkhof receives research grants from Centocor, Wyeth, Schering-Plough, Merck Serono, Abbott and Philips Lighting. E.M.G.J. de Jong served as a consultant for Biogen, Merck Serono, Wyeth and Abbott and has received research grants from or was involved in clinical trials from Schering-Plough, Abbott, Merck Serono, Wyeth, Centocor and Janssen-Cilag.

P.P.M. van Lümig. E-mail: P.vanLumig@derma.umcn.nl

Abstract

Background  The cumulative exposition to biologics is increasing with prolonged treatment with a certain biologic or consecutive biological treatment. However, long-term safety data are limited available.

Objectives  The aim of this study was to prospectively evaluate the 5-year safety of biological treatment for psoriasis in daily practice.

Methods  A cohort of 173 psoriasis patients on biologics was prospectively followed for 5 years. All adverse events reported were documented and analysed. Primary endpoint was the percentage of patients reporting at least one serious adverse event. The rate of malignancies, serious infections and serious cardiovascular events was compared with the general population incidence rate. The nature and rate of dermatological adverse events was compared with a group of prospectively followed rheumatoid arthritis patients on TNF-α blocking therapy.

Results  Between February 2005 and April 2010, 173 patients were enrolled in the registry and went through a total number of 263 treatment episodes. The total number of patient-years of follow-up in the registry was 409. The number of patient-years was the highest for etanercept. Forty-nine patients (28%) reported 88 serious adverse events. Only one serious adverse event was certainly causally related to the biologic and 21 events (24% of SAEs) were considered possibly related. The incidence of malignancies, serious infections and serious cardiovascular events was comparable with the population incidence rate, except for skin malignancies. The incidence of skin malignancies was significantly higher than the general population incidence rate. The nature and rate of dermatological adverse events differed from the rheumatoid arthritis cohort.

Conclusions  In this cohort, the safety of biological therapies for psoriasis was favourable with a low incidence of therapy-related serious adverse events.

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